Evaluation of MPM Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized Clinical Trial

Cairo University (CU)

Status and phase: Unknown; Early Phase 1

Conditions: Cleft; Alveolar Process

Treatments: Combination Product: MPM Prepared From Allogenic Bone Graft; Other: Autogenous bone

Study type: Interventional

Funder types: Other

Identifiers

NCT03420287

CEBD-CU-2018-01-02

Details and patient eligibility

About

The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and facilitate its handling and application during surgical grafting.This might decrease the need of the second surgical site for harvesting autogenous bone to be grafted with its all complications and hurdles.This trial will help the practitioners in taking the decision of using the MPM prepared from allogenic bone in alveolar cleft closure or not.

Full description

Alveolar bone grafting will be performed at 6 to 12 years of age as following :

Group (A):Will undergo grafting with anterior iliac crest bone,(Control group). Group (B):Will undergo grafting with Mineralized Plasmatic Matrix prepared from allogenic bone graft (study group).

In all patients, this will be the first bone graft to be placed in the alveolar cleft. All patients will be monitored clinically and radiographically (by cone beam C.T) for up to 6 months after surgery.

Enrollment: 56 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Unilateral or bilateral alveolar cleft patients

Exclusion criteria

• patients with previous failed alveolar cleft grafting procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

MPM prepared from allogenic bone graft

Experimental group

Description:

All patients in this group will receive MPM prepared from allogenic bone graft

Treatment:

Combination Product: MPM Prepared From Allogenic Bone Graft

Autogenous bone graft group

Active Comparator group

Description:

All patients in this group will receive autogenous bone graft only

Treatment:

Other: Autogenous bone